MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LARGE RING FUKUDA RETRACTOR WITH LARGE HANDLE; INSTRUMENT, EXTREMITY

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/18/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant products:bent ring fukuda retractor with angled tip pn994500850 lnzb140802.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent a total shoulder replacement.During the surgery, as the surgeon was attempting to gain access to the glenoid by retracting the shoulder muscles, the handles on both retractor components broke.The surgery was completed using an unknown retractor supplied by the hospital.No patient impact reported.

Manufacturer Narrative

Reported event was confirmed by review of returned product.The plastic handle of both devices is fractured along the connection point with the shaft of the retractors.It was reported in follow up that the retractors were used hundreds of times and were extremely worn, which could have possibly led to them fracturing during use.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-10778.

• Brand Name: LARGE RING FUKUDA RETRACTOR WITH LARGE HANDLE
• Type of Device: INSTRUMENT, EXTREMITY
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7094883
• MDR Text Key: 94412541
• Report Number: 0001825034-2017-10777
• Device Sequence Number: 1
• Product Code: GAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 406699
• Device Lot Number: ZB131101
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1